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news.The Finnish Medicines Agency (Fimea) has issued EU-GMP certificate to the Chinese drug developer Simcere Pharmaceutical's anti-diarrhea drug Biqi.
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The issuance of the certificate follows EU-GMP audit conducted by Fimea in April 2011.
The inspection covered product formulation, manufacturing process, facilities and quality management systems.
The results of the audit concludes that the drug met EU-GMP requirements for production and quality control.
Simcere chairman of the board Ren Jinsheng said they are pleased that Biqi has passed a high-standard quality control certification.